The PCA 3 system cam be used in a wide range of clinical settings — Class II medical device recall Z-2140-2016
Terminated recall by Hospira Inc., reported 2016-07-20, distributed nationwide. Hospira has received reports of PCA pumps not detecting distal occlusions, one of which resulted in a serious
| Recall number | Z-2140-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., Lake Forest, IL, United States |
| Recall initiated | 2013-03-08 |
| Classified | 2016-07-08 |
| Reported by FDA | 2016-07-20 |
| Terminated | 2016-11-07 |
| Distributed | Nationwide (US) |
| Quantity | 8,216 infusion |
| Reason classes | device malfunction |
| Serial numbers | 12920041, 12920048, 12920052, 12920056, 12920066, 12920069, 12920079, 12920082, 12920101, 12920102, 12920104, 12920105, 12920106, 12920107, 12920117, 12920121, 12920122, 12920152, 12920158, 12920159, 12920160, 12920174, 12920246, 12920248, 12920251 and 475 more |
Product
The PCA 3 system cam be used in a wide range of clinical settings, including but not limited to: general floor, labor/delivery,post-partum, burn unit, medical surgical, operating room, oncology, critical care units, post-anesthesia care unit (PACU), and pediatrics. The PCA 3 infusion pump allows clinicians to administer or patients to self-administer analgesia safely and effectively within clinician programmed limits. The epidural route can be used to provide anesthesia or analgesia.
Reason for recall
Hospira has received reports of PCA pumps not detecting distal occlusions, one of which resulted in a serious injury. The issue is caused by normal wear and tear on the Half Nut (the component/nut that travels up and down the lead screw) which prevents it from properly detecting the pressure build-up associated with a distal occlusion.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2140-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.